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News Breaks
August 11, 2014
16:24 EDTEXASFDA announces approval of Exact Sciences colorectal screening test
The FDA said it approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer. The FDA added that the Centers for Medicare & Medicaid Services proposes to cover the Cologuard test once every three years for Medicare beneficiaries who meet certain criteria. Cologuard is manufactured by Exact Sciences. Reference Link
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November 25, 2014
12:45 EDTEXASExact Sciences says CMS issues final payment decision regarding Cologuard
Exact Sciences announced that the Centers for Medicare & Medicaid Services,CMS, has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test. Cologuard is the first and only FDA-approved noninvasive stool DNA colorectal cancer screening test. The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program. Cologuard is the first technology to gain approval through this program. “CMS’ final payment decision represents a major milestone by providing 50M Medicare patients access to this noninvasive colorectal cancer screening option,” said Kevin Conroy, president, CEO and chairman of Exact Sciences. “We thank FDA and CMS for giving Exact Sciences the opportunity to bring this new screening option to patients and physicians.”
November 20, 2014
07:24 EDTEXASGoldman to hold a conference
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